French drug maker Sanofi and US-based Regeneron Pharmaceuticals have released positive results from a Phase III trial of investigational drug sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders to methotrexate (MTX) therapy.
The data showed that sarilumab increased major clinical response rates defined as achieving an ACR70 for at least 24 consecutive weeks, as well as showed sustained improvement in signs and symptoms of RA after 52 weeks, which were secondary endpoints of the trial.
The company said that in the SARIL-RA-MOBILITY Phase III trial, sarilumab met all three co-primary endpoints, showing improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progression at 52 weeks.
Stanford University Medical Center professor Mark Genovese, lead investigator in the study, said: "Despite notable advances, many RA patients continue to struggle with debilitating signs and symptoms, underscoring a clear need for additional options.
"Sarilumab showed efficacy in this study at two different doses, both delivered subcutaneously every other week.
"We look forward to the results of ongoing trials in this comprehensive registration programme."
A total of 1,197 adult patients with active, moderate-to-severe rheumatoid arthritis, who were inadequate responders to MTX therapy were enrolled in the Phase III trial.
Patients in the trial were randomised to one of three treatment groups dosed subcutaneously every other week, sarilumab 150mg, sarilumab 200mg, or placebo, all in combination with MTX.
Both sarilumab groups showed significant improvements compared with the placebo group in all three co-primary endpoints.
Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20% boost (ACR20).
Both doses also showed a sustained response in improvement of signs and symptoms of RA compared with placebo at 52 weeks as measured by the ACR20 response.
Infections were the most frequently reported adverse events and were reported with a higher incidence in the sarilumab groups compared to placebo, all in combination with MTX.
The sarilumab Phase III programme, also called as SARIL-RA, has six ongoing clinical studies and is targeted to enrol approximately 2,800 RA patients.